Clodifen
(Diclofenac sodium)




COMPOSITION

Each ampoule contains diclofenac sodium 75 mg.

THERAPEUTIC INDICATIONS

- Acute pain syndrome;
- Inflammatory and degenerate diseases of joints and vertebral column (including atrophic arthritis, ankylosing spondylitis (Bechterew's disease), osteoarthritis, gout, psoriatic arthritis, Reiter's disease);
- Rheumatic diseases of paraarticular soft tissues;
- Pains in case of vertebral column diseases;
- Neuralgia;
- Posttraumatic and postoperative painful conditions and hypostases;
- Primary dysmenorrhea, adnexitis, perimetritis;
- Fever by infectious-inflammatory diseases of ENT organs;
- Renal colic;
- Hepatic colic.

CONTRAINDICATIONS

- Hypersensitivity to the active compound diclofenac or any other NSAIDs;
- Hypersensitivity to acetylsalicylic acid and other NSAIDs, shown in the form of development of bronchial asthma attacks, occurrence of urticaria, acute rhinitis;
- Pathological changes of blood picture of not clear genesis;
- Stomach and duodenum ulcer;
- Destructive-inflammatory diseases of intestines in a phase of an aggravation;
- Pregnancy;
- Children and adolescents under 18 years old;
- Lactation (breast feeding must be terminated).

ADVERSE EFFECTS

GIT: Nausea, emesis, diarrhea including non-significant bleeding in GIT are more often reported.
Seldom anorexia, abdominal spasms, abdominal overfilling with gastrointestinal ulceration is observed. It may result in appearing of blood in stool.
CNS: Headache, dizzinesses, in rare cases – fatigue. In the extremely rare cases are possible infringements of: memory, orientation, sight, hearing; sleep frustration, spasm, irritability, tremor, mental infringements, depression, anxiety, taste infringement.
Dermatological reactions: skin rash is possible; seldom – urticaria. Separate rare cases of bullous urticaria, eczema, polymorphic erythema, Stevens-Johns's syndrome, Liyel's syndrome, photosensitization, purpura are described.
Kidneys: In rare cases renal dysfunction, proteinuria, hematuria and renal intestinal nephritis, nephrotic syndrome, papillary necrosis were observed.
Liver: Transit increasing of liver transaminase activity in blood. In rare cases – hepatitis (with or without jaundice).
From hematosis system: separate cases of development of thrombocytopenia, leukocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia are described.
Allergic reactions: seldom – attacks of bronchial asthma, systemic anaphylactic/anaphylactoid reactions (including arterial hypotension).
topical: morbidity and induration in places of injection is seldom noted, and in exceptional cases - development of soft tossues abscess and necrosis.

DOSAGE AND ADMINISTRATION

Only for intramuscular introduction!
Dose of the medicine is determined individually depending on disease.
For treatment of acute conditions or rapid relief of symptoms of chronic process introduce 75 mg of the medicine in the form of unitary IM injection. Solution is introduced deeply into a muscle in the top external square of a buttock.
In heavy cases it is possible to prescribe 2 injections a day with an interval of couple of hours, changing the parts of introduction. Administration of injections can be combined with other dosage forms of diclofenac, not exceeding a daily dose.
The maximal daily dose is 150 mg. Duration of administration of injection form of Clodifen usually is from 1 till 5 days.

DRUG INTERACTIONS

Co-administration of Clodifen:
with digoxin, fenitoine and other lithium drugs can cause increase of plasma level of these drugs;
with diuretics and hypotensive drugs may decrease pharmaceutical effect of these drugs;
with potassium-sparing diuretics may cause hyperpotassemia;
with cyclosporine may increase toxic action of cyclosporine on kidneys;
with acetylsalicylic acid decreases diclofenac plasma concentrations and increases risk of adverse effects;
with hypoglycemic agents may develops hypo- and hyperglycemia. This drug combination requires blood sugar level monitoring;
with methotrexate may increase Methotrexate concentration and intensify its toxic action;
with anticoagulants requires regular monitoring of blood coagulation.

PRECAUTIONS

It is necessary to be careful while prescribing the medicine Clodifen to the patients having in the anamnesis diseases of gastroenteric tract, peptic ulcer, ulcer colitis, Crone disease, and also to patients with the expressed infringements of liver function.
When decrease in volume of circulating blood (possible in case of diuretics reception; till or after serious operations), and also to patients with infringements of kidneys function, chronic intimate insufficiency, arterial hypertensia, Clodifen it is necessary to apply with care because of danger of reduction of renal blood flow.

PREGNANCY AND LACTATION

Administration during pregnancy and lactation is contraindicated.

MANUFACTURED FORM

Solution for IM injections. 75mg/3 ml in amber colored glass ampoules. 5 ampoules in a tray. 1 tray in a carton box with inserted leaflet.

Musculo-Skeletal system

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